Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:00 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT01106859
Description: None
Frequency Threshold: 0
Time Frame: Treatment emergent AEs (Day 1 to Week 6)
Study: NCT01106859
Study Brief: Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zopiclone Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet. None None 0 40 6 40 View
Zolpidem 4 Hours Prior A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving. None None 0 40 5 40 View
Zolpidem 3 Hours Prior A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving. None None 0 40 5 40 View
Placebo A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet. None None 0 40 4 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye inflammation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (13.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.0) View